At a recent Vietnam pharmaceutical industry meeting, healthy ministry officials stated that drug regulations needed to be ramped up and drug prices regulated more strictly. Vietnam’s pharmaceutical companies mostly manufacture generic products for simple illnesses. Many specialized drugs such as HIV and... Read More
ASEAN industry members assembled in the Philippines in January 2008 to announce committee members of the new ASEAN Medical Device Industry Association (AMDIA). AMDIA is focused on representing the common regulatory interest of the medical device industry in ASEAN. It will also... Read More
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More
After joining the WTO in January 2007, Vietnam has seen a sharp increase in foreign investment in its pharmaceutical industry. In 2007 alone, there were 58 new foreign businesses in this industry. Vietnam’s Ministry of Health reported that by the end of... Read More
The Asian Harmonization Working Party (AHWP) had its last meeting on October 26 and 27 in Chengdu, China, where it discussed schedules and plans for the Common Submission Dossier Template (CSDT), Post-market Alert Systems (PMAS) and other tasks. For CSDT and PMAS,... Read More
The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality (ACCSQ-MDPWG) held a meeting from July 30 to August 2, 2007. In this meeting, the ASEAN (Association of Southeast Asian Nations) countries discussed proposals for conformity assessment... Read More
This report helps medical device manufacturers and distributors better understand how to source from Asia. Topics covered include: how to identify manufacturers, how to perform due diligence, what to look for during factory visits, contract negotiations, regulatory requirements, logistics, quality control, and... Read More
Vietnam’s Ministry of Health (MOH) recently issued new regulations on drug prices. Currently, most price controls in Vietnam are enforced by mandatory reporting. Under the new laws, prices will be more directly administered. Drug pricing will be split into three segments, each... Read More
Earlier this spring, Vietnam’s Ministry of Health conducted drug price audits with recent reports of price hikes. Visiting local pharmacies, representative offices of pharmaceutical firms and drug wholesalers, the Ministry of Health found 13 pharmaceutical companies increasing prices without appropriate government approval.... Read More
The Medical Device Product Working Group of the ASEAN Consultative Committee for Standards and Quality held a meeting from July 30 to August 2, 2007 to discus various topics and strategies to increase harmonization of medical device regulations across the ASEAN countries.... Read More